Ananya Bhat

Senior Clinical Data Coordinator

IQVIA

Bangalore

12.2021 - Current

In accordance with project-specific timelines, perform data management activities to ensure the generation of accurate, complete, and consistent clinical databases.
Ensure all work performed is of high quality, compliant with good clinical practice, ICH guidelines, and all applicable laws and regulations.
Review CRF/eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks.
Perform user acceptance testing, and collaboratively work with CDMS personnel to address issues found through retesting and resolution.
Experience in external vendor data import setup, drafting of external data reconciliation specifications.
Validation of data listings.
Perform external data and serious adverse event reconciliation.
Creation of Clean Patient Tracker, Missing Pages Report, CRF Completion Guidelines.
Also, I have been a part of training programs where I have trained the Clinical Data Coordinators on topics like ALS, the setup of external data and the reconciliation, and UAT of edits and CRFs.
Managed the delivery of projects through the full data management study life cycle (with minimal guidance) from DTL, and managed project timelines and quality.
Perform comprehensive data management tasks, including data review, writing, and resolving data clarifications.
Conducted quality control procedures.
Participated in internal audits.
Develop and maintain good communications and working relationships with the CDM team.
Interact with CDM team members to negotiate timelines and responsibilities.
I have been a part of multiple milestones: interim analysis and database lock.